Arthroscopic Shoulder SurgeryNCT03212443
Combined Suprascapular and Axillary Nerve Blocks for Arthroscopic Shoulder Surgery
A study testing Suprascapular nerve- axillary nerve block combination and Subacromial infiltration in people with Arthroscopic Shoulder Surgery and Suprascapular Nerve Block, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Arthroscopic shoulder surgery is associated with severe pain postoperatively. Regional nerve block adding to general anesthesia might improve the quality of postoperative analgesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthroscopic Shoulder Surgery, Suprascapular Nerve Block, Axillary Nerve Block
- What is being tested?
- Suprascapular nerve- axillary nerve block combination and Subacromial infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2017to 22 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American society of anesthesia physical status (ASA) 1,2 patients
- Elective arthroscopic shoulder surgery
Who cannot join
- ASA 3,4 patients
- Coagulation abnormality
- Body mass index >30
- Preexisting neurological deficit Local anesthetic allergy history Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Suprascapular and Axillary Nerve Blocks for Sevoflurane Consumption and Postoperative Analgesia in Arthroscopic Shoulder Surgery
Arthroscopic shoulder surgery is associated with severe pain postoperatively. Regional nerve block adding to general anesthesia might improve the quality of postoperative analgesia. The aim of the study is to compare the subacromial local anesthetic infiltration and the suprascapular-axillary nerve blocks combination for intraoperative sevoflurane consumption, postoperative analgesia and analgesic consumption.
Read the detailed description
After informed consent and with ethics approval, 60 ASA 2-3 patients scheduled for elective arthroscopic shoulder surgery will be included in this study. Patient will be divided to two groups by using computer -generated list for randomization. In group A, the surgeon will apply 20 ml of 0.250% bupivacaine to the subacromial region at the end of the procedure. In Group B, suprascapular (10 ml of 0.250% bupivacaine ) and axillary block (10 ml of 0.250% bupivacaine) will be performed with ultrasound and nerve stimulator guidance before induction of anesthesia. In all patients after standard and BIS (Bi spectral index) monitorization general anesthesia will be induced with remifentanil (10mcg iv), propofol (2.5 mg/kg iv) and rocuronium (0.5mg/kg iv). After intubation, anesthesia will be maintained with 50% O2 and N2O mixture. Hemodynamic parameters, BIS values, end-tidal sevoflurane consumption will be recorded by blind investigator. Postoperative visual analog scale (VAS) values, postoperative analgesic consumption (Tramadol, patient controlled analgesia), complications will be recorded.
- Being tested
- Suprascapular nerve- axillary nerve block combination, Subacromial infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprascapular nerve- axillary nerve block combinationProcedure or surgery
In Group B, suprascapular (10 ml of 0.250% bupivacaine ) and axillary block (10 ml of 0.250% bupivacaine) will be performed with ultrasound and nerve stimulator guidance before induction of anesthesia
Subacromial infiltrationProcedure or surgery
In group A, the surgeon will apply 20 ml of 0.250% bupivacaine to the subacromial region at the end of the procedure
| Study group | Role | What they receive |
|---|---|---|
| Group A | Sham comparator | In group A, the surgeon will apply 20 ml of 0.250% bupivacaine to the subacromial region at the end of the procedure Receives: Procedure: Subacromial infiltration |
| Group B | Active comparator | In Group B, suprascapular (10 ml of 0.250% bupivacaine ) and axillary block (10 ml of 0.250% bupivacaine) will be performed with ultrasound and nerve stimulator guidance before induction of anesthesia Receives: Procedure: Suprascapular nerve- axillary nerve block combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative VAS scores
Ranging from 0: no pain to 10: worst pain
Measured: Through postoperative period, an avarage of 30 minutes
Secondary outcomes (1)
sevoflurane consumption
End tidal sevoflurane concentration values assesment during the surgery
Measured: 5th, 10th,20th,30th,40th,50th minutes after induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start10 Aug 2017
- Primary completion25 Feb 2018
- Study completion22 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthroscopic Shoulder SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, derya özkan, Diskapi Teaching and Research Hospital
- Investigators
- Derya Ozkan, Principal investigator, Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212443
- Sponsor's protocol ID
- Diskapi4
- Status last verified
- Aug 2018
- First submitted
- 4 Jul 2017
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dhir S, Sondekoppam RV, Sharma R, Ganapathy S, Athwal GS. A Comparison of Combined Suprascapular and Axillary Nerve Blocks to Interscalene Nerve Block for Analgesia in Arthroscopic Shoulder Surgery: An Equivalence Study. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):564-71. doi: 10.1097/AAP.0000000000000436.
PubMed 27380105Ritchie ED, Tong D, Chung F, Norris AM, Miniaci A, Vairavanathan SD. Suprascapular nerve block for postoperative pain relief in arthroscopic shoulder surgery: a new modality? Anesth Analg. 1997 Jun;84(6):1306-12. doi: 10.1097/00000539-199706000-00024.
PubMed 9174311
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Suprascapular and Axillary Nerve Blocks for Sevoflurane Consumption and Postoperative Analgesia in Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT03212443
- Acronym / sponsor ID
- Diskapi4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 25 Feb 2018 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Arthroscopic shoulder surgery is associated with severe pain postoperatively. Regional nerve block adding to general anesthesia might improve the quality of postoperative analgesia. The aim of the study is to compare the subacromial local anesthetic infiltration and the suprascapular-axillary nerve blocks combination for intraoperative sevoflurane consumption, postoperative analgesia and analgesic consumption.
Detailed description
After informed consent and with ethics approval, 60 ASA 2-3 patients scheduled for elective arthroscopic shoulder surgery will be included in this study. Patient will be divided to two groups by using computer -generated list for randomization. In group A, the surgeon will apply 20 ml of 0.250% bupivacaine to the subacromial region at the end of the procedure. In Group B, suprascapular (10 ml of 0.250% bupivacaine ) and axillary block (10 ml of 0.250% bupivacaine) will be performed with ultrasound and nerve stimulator guidance before induction of anesthesia. In all patients after standard and BIS (Bi spectral index) monitorization general anesthesia will be induced with remifentanil (10mcg iv), propofol (2.5 mg/kg iv) and rocuronium (0.5mg/kg iv). After intubation, anesthesia will be maintained with 50% O2 and N2O mixture. Hemodynamic parameters, BIS values, end-tidal sevoflurane consumption will be recorded by blind investigator. Postoperative visual analog scale (VAS) values, postoperative analgesic consumption (Tramadol, patient controlled analgesia), complications will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Sham comparator | Procedure: Subacromial infiltrationIn group A, the surgeon will apply 20 ml of 0.250% bupivacaine to the subacromial region at the end of the procedure |
| Group B | Active comparator | Procedure: Suprascapular nerve- axillary nerve block combinationIn Group B, suprascapular (10 ml of 0.250% bupivacaine ) and axillary block (10 ml of 0.250% bupivacaine) will be performed with ultrasound and nerve stimulator guidance before induction of anesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American society of anesthesia physical status (ASA) 1,2 patients
- Elective arthroscopic shoulder surgery
Key exclusion criteria (4 listed)
- ASA 3,4 patients
- Coagulation abnormality
- Body mass index >30
- Preexisting neurological deficit Local anesthetic allergy history Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suprascapular nerve- axillary nerve block combinationIn Group B, suprascapular (10 ml of 0.250% bupivacaine ) and axillary block (10 ml of 0.250% bupivacaine) will be performed with ultrasound and nerve stimulator guidance before induction of anesthesia | Procedure or surgery | Group B |
| Subacromial infiltrationIn group A, the surgeon will apply 20 ml of 0.250% bupivacaine to the subacromial region at the end of the procedure | Procedure or surgery | Group A |
Primary outcome
Postoperative VAS scores
Time frame: Through postoperative period, an avarage of 30 minutes
Ranging from 0: no pain to 10: worst pain
1 secondary outcome
sevoflurane consumption
Time frame: 5th, 10th,20th,30th,40th,50th minutes after induction of anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Results publication: PubMed 27380105Dhir S, Sondekoppam RV, Sharma R, Ganapathy S, Athwal GS. A Comparison of Combined Suprascapular and Axillary Nerve Blocks to Interscalene Nerve Block for Analgesia in Arthroscopic Shoulder Surgery: An Equivalence Study. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):564-71. doi: 10.1097/AAP.0000000000000436.
- Results publication: PubMed 9174311Ritchie ED, Tong D, Chung F, Norris AM, Miniaci A, Vairavanathan SD. Suprascapular nerve block for postoperative pain relief in arthroscopic shoulder surgery: a new modality? Anesth Analg. 1997 Jun;84(6):1306-12. doi: 10.1097/00000539-199706000-00024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derya Ozkan principal investigator
Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suprascapular nerve- axillary nerve block combination and Subacromial infiltration in people with Arthroscopic Shoulder Surgery and Suprascapular Nerve Block, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative VAS scores (time frame: Through postoperative period, an avarage of 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03212443, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.